跳至主要内容
临床试验/NCT01110564
NCT01110564已完成不适用

A Cross-sectional Observational Study to Investigate Daily Symptom Variability, Effects of Symptom on Morning Activities and Therapeutic Expectations of Patients and Physicians in Chronic Obstructive Pulmonary Disease - SUNRISE Study

AstraZeneca1 个研究点 分布在 1 个国家目标入组 515 人开始时间: 2010年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
AstraZeneca
入组人数
515
试验地点
1
主要终点
To evaluate daily symptom variability in Chronic Obstructive Pulmonary Disease (COPD) patients

研究概览

简要总结

The primary objective of this non-interventional study is to evaluate daily symptom variability in COPD patients. The secondary objectives are; to evaluate effects of COPD symptoms on the morning activities of patients, to determine therapeutic expectations of patients and physicians in COPD, to determine which and how frequent non-drug approaches are recommended in order to prevent COPD exacerbations, to define COPD patient profiles about the below-mentioned issues: Demographic characteristics, Disease characteristics, Concomitant diseases and implemented drug treatments. All patients, who apply to the study physicians and fulfill all patient selection criteria during patient enrolment period, will be included. Patients, who provide all of the following measures will be included in the study: To apply to a physician for outpatient treatment for any reason, Age over 45 years, being diagnosed with COPD, being a smoker or used to be a smoker once (> 10 package years), to give consent for the use of their medical data. The patients that exhibit the following exclusion criteria will be excluded from the study: COPD exacerbations still on-going or experienced in the last 3 months (Exacerbation is defined as worsening of COPD symptoms leading to antibiotic and/or short-term oral steroid treatment and/or hospitalization or admission to the emergency unit.); Presence of lung cancer or an important respiratory disease such as bronchiectasis, pulmonary fibrosis, interstitial pulmonary disease, tuberculosis, sarcoidosis; Participation in an interventional clinical trial at present and Enrollment in this study once. In this study, patients will be recorded at their visit to the physician and there will be no follow-up thereafter.

研究设计

研究类型
Observational
时间视角
Cross Sectional

入排标准

年龄范围
45 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • To apply to a physician for outpatient treatment for any reason; being diagnosed with COPD
  • being a smoker or used to be a smoker once (> 10 package years)
  • to give consent for the use of their medical data

排除标准

  • COPD exacerbations still on-going or experienced in the last 3 months
  • Presence of lung cancer or an important respiratory disease such as bronchiectasis, pulmonary fibrosis, interstitial pulmonary disease, tuberculosis, sarcoidosis
  • Participation in an interventional clinical trial at present and Enrollment in this study once

结局指标

主要结局

To evaluate daily symptom variability in Chronic Obstructive Pulmonary Disease (COPD) patients

时间窗: April - Dec 2010

次要结局

  • To evaluate effects of COPD symptoms on the morning activities of patients; To determine therapeutic expectations of patients and physicians in COPD(April - Dec 2010)
  • To define COPD patient profiles about the below-mentioned issues: Demographic characteristics; Disease characteristics; Concomitant diseases; Implemented drug treatments(April - Dec 2010)
  • To determine which and how frequent non-drug approaches are recommended in order to prevent COPD exacerbations(April - Dec 2010)

研究者

发起方
AstraZeneca
申办方类型
Industry

研究点 (1)

Loading locations...

相似试验